Nctid:
NCT06236789
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D000005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000011469", "term"=>"Prostatic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostatic Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000007069", "term"=>"Ifosfamide"}], "ancestors"=>[{"id"=>"D000018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000000477", "term"=>"Alkylating Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M10117", "name"=>"Ifosfamide", "asFound"=>"Intraoperative", "relevance"=>"HIGH"}, {"id"=>"M230811", "name"=>"Isophosphamide mustard", "relevance"=>"LOW"}, {"id"=>"M17811", "name"=>"Mesna", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2016-11", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-11", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-11", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Objective response rate", "timeFrame"=>"Up to 2 years", "description"=>"Summation of complete response partial response based on RECIST version 1.1"}], "secondaryOutcomes"=>[{"measure"=>"Number of patients with Adverse events based on CTCAE", "timeFrame"=>"Up to 2 years", "description"=>"Adverse events based on CTCAE"}, {"measure"=>"Overall survival", "timeFrame"=>"Up to 2 years", "description"=>"From date of treatment start to death"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Castration-resistant prostate cancer", "Ifosfamide/mesna", "Efficacy", "Safety"], "conditions"=>["Prostatic Neoplasm"]}, "descriptionModule"=>{"briefSummary"=>"Prostate cancer is the 2nd most common cancer in men worldwide. Based on the results of several recent clinical trials, systemic treatments including hormone inhibitors, docetaxel, cabazitaxel, and PARP inhibitors are being used as standard treatment for patients with metastatic castration-resistant prostate cancer. However, there is insufficient research on salvage therapy for patients with metastatic castration-resistant prostate cancer who have failed standard treatment. In this study, the investigators will evaluate the effectiveness and safety of ifosfamide in castration-resistant prostate cancer by analyzing the treatment outcomes of patients who received ifosfamide/mesna treatment as salvage therapy.", "detailedDescription"=>"1. Retrospective analysis of the treatment outcomes of patients with metastatic castration-resistant prostate cancer who who received ifosfamide/mesna will be conducted.\n2. Information regarding demographics (age, gender, and etc.), disease status (stage, metastatic lesion, and etc.), treatment details (administered anticancer drugs, treatment response to drug, and disease progression with progression date), and survival (death with date of death) will be recorded.\n3. Statistical method was applied to analyze the correlation between clinical indicators and survival rate."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"19 years", "genderBased"=>true, "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with metastatic castration-resistant prostate cancer", "genderDescription"=>"Patients with prostate cancer", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. 19 years and older adult male\n2. Patients with histologically confirmed prostate cancer\n3. Castration-resistant prostate cancer\n4. ECOG 2 or less\n5. Patients with previous docetaxel exposure\n6. Patients with available PSA level\n7. Patients with evaluable disease based on RECIST 1.1\n\nExclusion Criteria:\n\n1. Patients with other primary cancers diagnosed within 3 years other than prostate cancer\n2. Patients with a history of organ transplantation\n3. Hormone sensitive prostate cancer\n4. ECOG 3 or higher\n5. Patients without previous docetaxel exposure\n6. Patients previously exposed to ifosfamide\n7. Patients without available PSA level\n8. Patients without evaluable disease based on RECIST 1.1"}, "identificationModule"=>{"nctId"=>"NCT06236789", "briefTitle"=>"Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Yonsei University"}, "orgStudyIdInfo"=>{"id"=>"4-2023-1306"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Castration-resistant prostate cancer patients treated with ifosfamide/mesna", "interventionNames"=>["Drug: Ifosfamide/mesna"]}], "interventions"=>[{"name"=>"Ifosfamide/mesna", "type"=>"DRUG", "description"=>"Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression", "armGroupLabels"=>["Castration-resistant prostate cancer patients treated with ifosfamide/mesna"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Seoul", "status"=>"RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Sang Joon Shin", "role"=>"CONTACT", "email"=>"inspector@yuhs.ac", "phone"=>"82-2-2228-8130"}], "facility"=>"Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "centralContacts"=>[{"name"=>"Sang Joon Shin", "role"=>"CONTACT", "email"=>"inspector@yuhs.ac", "phone"=>"82-2-2228-8130"}], "overallOfficials"=>[{"name"=>"Sang Joon Shin", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"Additional information reported in this study will be available upon request."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yonsei University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
